Alzheimer's Disease Vaccines 2022
According to the Alzheimer's Association, Alzheimer's disease (AD) is a degenerative brain disease caused by complex brain changes following cell damage, leading to dementia symptoms that gradually worsen over time.
However, the U.S. FDA had not authorized preventive Alzheimer's disease vaccines as of November 22, 2022. Currently, there are sponsored clinical studies in progress developing Alzheimer's vaccines.
Alzheimer's Disease and Influenza Vaccination
A study from UTHealth Houston, announced on June 24, 2022, found that people who received at least one influenza vaccination were 40% less likely to develop AD over four years. A separate study published on August 2, 2022, supported that finding: The RR was 0.60 (95% CI, 0.59–0.61), and ARR was 0.034 (95% CI, 0.033–0.035), corresponding to a number needed to treat of 29.4.
Alzheimer's Vaccine Candidates 2022
AADvac1 is a therapeutic vaccine candidate for Alzheimer's disease that targets misfolded tau protein, a common denominator of neurofibrillary pathology.
ACI-24 is an amyloid-beta (Abeta) vaccine owned by AC Immune and derived from the Company's SupraAntigen® platform. It is designed to prevent Abeta plaque accumulation and enhance plaque clearance by generating antibodies against pathological Abeta, including oligomeric Abeta and pyroGlu-Abeta. AC Immune will be initiating clinical testing of the optimized ACI-24 formulation in 2022.
ACI-35.030 is a first-in-class AD vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. AC Immune is collaborating with Janssen Pharmaceuticals, Inc. Recent results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, ePHF. In addition, the ACI-35.030-induced antibody response was sustained and could be periodically boosted over 72 weeks.
Alzinova's ALZ-101 vaccine candidate is investigating two different dose strengths of ALZ-101 in a phase 1 study during a treatment period of 20 weeks. Alzinova is the first Company with an oligomer-specific vaccine in the clinical phase.
Vaxxinity's UB-311 is an immunotherapeutic vaccine candidate targeting toxic forms of aggregated amyloid-beta in the brain to treat Alzheimer's disease. Phase 1, Phase 2a, and Phase 2a LTE trials have shown UB-311 to be highly immunogenic with a high responder rate and antibodies that bind to the desired target. As a result, it was granted U.S. FDA Fast Track status.
Alzheimer's Antibody Treatment Candidates 2022
Aduhelm is an amyloid beta-directed antibody injection of 100 mg/mL for intravenous use indicated to treat AD.
ProMIS' therapeutic product candidate PMN310 is a monoclonal therapeutic antibody designed to treat AD.
Alzamend Neuro, Inc.'s AL001 is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline, and salicylate to treat Alzheimer's and other neurodegenerative diseases and psychiatric disorders. ALZN002 immunotherapy is intended to treat patients diagnosed with Alzheimer's by inducing the patient's antibodies. These are targeted to remove the Aβ1‑42 protein, reducing the deposition of amyloid plaque in the brain and thereby reducing the progression of disease-associated clinical signs and symptoms.
Prothena Corporation's PRX012 is a next-generation, high-binding potency antibody designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for AD patients and caregivers. Accordingly, the U.S. FDA granted Fast Track Designation on April 26, 2022.
Alzinova AB's ALZ101 is an active, therapeutic oligomer-specific vaccine candidate that stimulates the production of antibodies against the toxic Aβ oligomers. The first-in-human phase 1b study in patients with early AD was initiated in 2021. Alzamend is also pursuing AL001 for the treatment of bipolar disorder and PTSD. Topline data for the analysis is anticipated in the second half of 2023.
Biogen Inc. Lecanemab (BAN2401) is an investigational humanized monoclonal antibody for AD resulting from a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD.
The U.S. FDA permitted marketing on May 4, 2022, for Fujirebio Diagnostics, Inc. Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test intended to be used in adult patients aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.
Alzheimer's Vaccine Clinical Trials
Clinical trials are listed on this sponsored website.
Alzheimer's Vaccine News 2022
November 30, 2022 - AC Immune announced data presented at CTAD 2022 confirmed an excellent clinical performance of the ACI-35.030 vaccine candidate. Based on this new clinical data, ACI-35.030 has been selected for further development representing significant progress for the anti-pTau vaccine candidate.
November 28, 2022 - A recent dementia vaccine study published in the International Journal of Molecular Sciences reported on the development of a vaccine in the form of the recombinant protein, PV-1950R, formulated in adjuvant.
November 27, 2022 - A recent clinical trial death, described in an unpublished case report, Science obtained, is the second thought associated with Biogen Inc.'s antibody lecanemab.
November 21, 2022 - EmbarkNeuro announced that the first patient had been dosed in its Phase 2 trial of ANC-501, a first-in-class vasopressin 1b (V1b) receptor antagonist for the treatment of the major depressive disorder. This 8-week single-arm trial will assess the efficacy of ANC-501 when added to standard antidepressant therapy in patients with biomarker-confirmed disruption in their stress-response system.
November 17, 2022 - Published in the journal Nature, the protein medin is deposited in the blood vessels of the brains of Alzheimer's patients along with the protein amyloid-β, according to researchers from DZNE.
October 31, 2022 - Alzamend Neuro announced receipt of a "Study May Proceed" letter from the U.S. FDA for a phase I/IIA clinical trial under its IND application for ALZN002.
October 5, 2022 - Alzamend Neuro, Inc. announced it dosed its first healthy adult in its Phase IIA multiple ascending dose study of AL001 in subjects with dementia related to Alzheimer's.
September 27, 2022 - Biogen and Eisai's investigational Alzheimer's disease treatment slowed the rate of cognitive decline by 27% in a clinical trial.
September 13, 2022 - IOS Press published: Association of COVID-19 with New-Onset Alzheimer's Disease. 'We show that people with COVID-19 were at significantly increased risk for a new diagnosis of Alzheimer's disease within 360 days after the initial COVID-19 diagnosis (hazard ratio or HR:1.69, 95% CI: 1.53–1.72), especially in people aged≥85 years and in women.'
September 7, 2022 - Alzinova AB announced a second external safety review had been carried out of the Company's phase 1b clinical study of ALZ-101, with a positive assessment to continue the study as planned. The ALZ-101 study for early Alzheimer's disease is a placebo-controlled, double-blind, randomized First In Human clinical trial.
August 2, 2022 - Researchers at Tufts University and The University of Oxford demonstrated the presence of two viruses that can promote excess proteins responsible for Alzheimer's characteristic brain plaques. Conclusion: Our results are consistent with the suggestion that shingles cause reactivation of HSV1 in the brain and with the protective effects against AD of various vaccines, as well as the decrease in herpes labialis reported after certain types of vaccination.
August 1, 2022 - Vaxxinity, Inc. presented new preclinical data on vaccine candidates targeting aberrant forms of the Tau protein for Alzheimer's disease. The poster "Characterization of Tau vaccines identifies diverse antibody binding and efficacy profiles." "Our findings show that vaccines can target specific forms of Tau with subsequent functional impact," said Justin Boyd, Ph.D., Director of Translational Science at Vaxxinity.
July 20, 2022 - Blue Water Vaccines Inc. announced a Sponsored Research Agreement with Cincinnati Children's Hospital Medical Center to explore vaccine development for multiple diseases. Ming Tan, Ph.D., associate professor in the Division of Infectious Diseases, is the principal investigator for the research at Cincinnati Children's.
July 18, 2022 - Alzamend Neuro, Inc. announced that it had received a written response to its meeting request relating to its Type B Pre-Investigational New Drug Application from the U.S. FDA that provides a path for the planned clinical development of AL001 for the treatment of the bipolar disorder, MDD, and PTSD.
July 5, 2022 - Alzinova AB announced it successfully verified that the manufacturing process for vaccine doses of ALZ-101, the Company's vaccine candidate against Alzheimer's disease, can be scaled up to deliver larger production volumes required for clinical phase 2 trials.
July 4, 2022 - Research published in the Journal of Alzheimer's Disease suggests that a multimodal approach to Alzheimer's and dementia prevention may slow and even reverse advanced cognitive decline.
June 30, 2022 - The Alzheimer's Association published - Genome-wide association and multi-omics studies identify MGMT as a novel risk gene for Alzheimer's disease (AD) among women. To identify novel genes associated with tau-related pathology, we conducted two genome-wide association studies for AD, one among 10,340 ε4– women in the Alzheimer's Disease Genetics Consortium and another in 31 members (22 women) of a consanguineous Hutterite kindred. The findings suggest that epigenetically regulated MGMT expression is involved in AD pathogenesis, especially in women.
June 13, 2022 - People who received at least one influenza vaccine were 40% less likely than their non-vaccinated peers to develop Alzheimer's disease over four years, according to a new study from UTHealth Houston.
May 5, 2022 - Alzamend Neuro, Inc. announced the first patient with mild to moderate Alzheimer's had been dosed in a Phase IIA study for dementia related to Alzheimer's.
May 2, 2022 - Vaxxinity, Inc. announced that the U.S. FDA granted UB-311 Fast Track Designation to treat Alzheimer's disease.
April 28, 2022 - Alzinova AB announces that the Data and Safety Monitoring Board completed a planned assessment of the ongoing ALZ-101 Phase 1b clinical study and recommended continuing the study.
April 26, 2022 - Prothena Corporation plc announced that the U.S. FDA granted Fast Track designation for PRX012, a potential best-in-class anti-amyloid beta (Aβ) antibody therapy for treating Alzheimer's disease.
April 26, 2022 - The four-year BrainHOPE project will use brain imaging and a range of tests to compare brain health in mid-life former footballers with members of the general population. This new study builds on the FIELD study, which found the risk of dementia and related disorders among former professional footballers was around 3.5 times higher than expected.
April 20, 2022 - The journal Nature published: Somatic genomic changes in single Alzheimer's disease neurons. 'Our results suggest that known pathogenic mechanisms in Alzheimer's disease may lead to genomic damage to neurons that can progressively impair function. Furthermore, the aberrant accumulation of DNA alterations in neurodegeneration provides insight into the cascade of molecular and cellular events in the development of Alzheimer's disease.'
April 13, 2022 - Results from a significant study highlight the need to continuously monitor breakthrough SARS-CoV-2 infections and outcomes in vaccinated patients with dementia.
April 5, 2022 - The journal Nature Neuroscience published a study: Genetic variants associated with longitudinal changes in brain structure across the lifespan. Gene set findings to implicate both early brain development and neurodegenerative processes in the rates of brain changes. Identifying variants involved in structural brain changes may help determine biological pathways underlying optimal and dysfunctional brain development and aging.
April 4, 2022 - The journal Nature Genetics published a study that performed a two-stage genome-wide association study totaling 111,326 clinically diagnosed/‘proxy' AD cases. They found 75 risk loci, of which 42 were new at the analysis time. Pathway enrichment analyses confirmed the involvement of amyloid/tau pathways and highlighted microglia implications. In addition, Gene prioritization in the new loci identified 31 genes suggestive of new genetically associated processes, including the tumor necrosis factor-alpha pathway through the linear ubiquitin chain assembly complex.
March 30, 2022 - Alzinova AB announced its drug substance manufacturing partner, Bachem (Switzerland), had optimized the manufacturing process of the active ingredient in ALZ-101, a vaccine in clinical development for the treatment of Alzheimer's disease.
March 28, 2022 - Alzamend Neuro, Inc. announced that it had received the full data set from its Phase 1 clinical trial for AL001. These data affirmed that dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma indicate that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product, and the shapes of the lithium plasma concentration versus time curves are similar. In addition, AL001 salicylate plasma concentrations were well-tolerated and consistently within safe limits, and the safety profiles of AL001 and the marketed lithium carbonate capsule were benign. These data will help Alzamend establish doses for a planned Phase 2 multiple ascending dose studies in Alzheimer's disease patients.
March 28, 2022 - Prothena Corporation plc announced that the U.S. FDA had cleared the investigational new drug application for PRX012, a potential best-in-class anti-amyloid beta antibody in development for AD treatment.
March 23, 2022 - The Alzheimer's Association published a Research Article: Midlife lipid and glucose levels are associated with Alzheimer's disease. High-density lipoprotein (HDL) cholesterol and triglyceride levels were linked with Alzheimer's dementia decades later in life. The risk of Alzheimer's dementia fell by 15.4% during early adulthood (ages 35 to 50) for every 15 mg/dL increase in HDL cholesterol, reported Xiaoling Zhang, MD, Ph.D., of Boston University School of Medicine and co-authors in Alzheimer's & Dementia.
March 22, 2022 - ProMIS Chief Development Officer Dr. Johanne Kaplan delivered an oral presentation entitled: "Optimizing vaccine design for Alzheimer's disease: selective targeting of computationally-derived conformational B cell epitopes of soluble amyloid-beta toxic oligomers." The presentation discussed the design of an amyloid-beta (Aβ) vaccine to elicit selective antibodies for toxic amyloid-beta oligomers (AβO) without inducing a potentially detrimental immune response to normal forms of Aβ.
March 16, 2022 - Biogen Inc. announced new data showing that after nearly two and a half years of treatment (128 weeks) with ADUHELM® injection 100 mg/mL for intravenous use, patients in the long-term extension phase of the Phase 3 trials continued to experience significant reductions in two key Alzheimer's disease pathologies, amyloid-beta plaques, and plasma p-tau181. The data also show that in both Phase 3 trials, at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced.
March 16, 2022 - Prothena Corporation plc presented new preclinical data from its dual Aβ/tau vaccine for the potential treatment and prevention of AD and its tandem C-terminal α-synuclein vaccine programs for the potential treatment and prevention of Parkinson's disease and related synucleinopathies. Prothena's dual Aβ/tau vaccines were described as linear peptide conjugates designed to prevent the two key processes associated with AD: 1) the formation of Aβ-plaque and 2) the development of intraneuronal tau tangles.
March 15, 2022 - Araclon Biotech advances in its innovative vaccine and diagnostic test for Alzheimer's. Presented ABvac40 and ABtest-MS study results at the AD/PD™ 2022 Conference in Barcelona.
March 14, 2022 - A $289 million increase for Alzheimer's and dementia research funding at the U.S NIH was signed into law. Added to current NIH spending, the federal government's annual Alzheimer's and dementia research funding is up to $3.5 billion.
February 4, 2022 - AC Immune SA announced that preclinical data on the optimized formulation of its amyloid-beta (Abeta) vaccine program, ACI-24, were published in the peer-reviewed journal Brain Communications. As a result, AC Immune plans to advance the clinical development of the optimized formulation to the next stage for both Alzheimer's disease and Down syndrome-related AD in 2022.
November 16, 2022 - Brigham and Women's Hospital is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow AD progression. The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. Protollin is composed of bacteria-derived proteins and has been used safely in humans as an adjuvant for other vaccines.
June 27, 2020 - People who received at least one flu vaccination were 17% less likely to get Alzheimer's disease over the course of a lifetime, according to researchers at The University of Texas Health Science Center at Houston.
The most common early symptom of Alzheimer's is trouble remembering new information because the disease typically impacts the part of the brain associated with learning first, writes the U.S. NIH. Although most people with Alzheimer's are 65 and older, it is not a normal part of aging. In fact, the U.S. CDC says 'about 200,000 people 65 years and younger live with early-onset AZD.
Early-onset AZD is still a mystery; however, a genetic component has been identified. When Alzheimer's is caused by these genes, it is called "familial Alzheimer's disease." About 25% of all Alzheimer's disease is familial.
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